Spironolactone Versus Clonidine as a Fourth-Drug Therapy for Resistant Hypertension: The ReHOT Randomized Study (Resistant Hypertension Optimal Treatment)

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Krieger, Eduardo M. ^[1] ; Drager, Luciano F. ^{[1, 2]} ; Giorgi, Dante M. A. ^[1] ; Pereira, Alexandre C. ^[3] ; Soares Barreto-Filho, Jose Augusto ^[4] ; Nogueira, Armando R. ^[5] ; Mill, Jose Geraldo ^[6] ; Lotufo, Paulo A. ^[7] ; Amodeo, Celso ^[8] ; Batista, Marcelo C. ^[9] ; Bodanese, Luiz C. ^[10] ; Carvalho, Antonio C. C. ^[11] ; Castro, Iran ^[12] ; Chaves, Hilton ^[13] ; Costa, Eduardo A. S. ^[14] ; Feitosa, Gilson S. ^[15] ; Franco, Roberto J. S. ^[16] ; Fuchs, Flavio D. ^[17] ; Guimaraes, Armenio C. ^[18] ; Jardim, Paulo C. ^[19] ; Machado, Carlos A. ^[20] ; Magalhaes, Maria E. ^[21] ; Mion, Jr., Decio ^[2] ; Nascimento, Raimundo M. ^[22] ; Nobre, Fernando ^[23] ; Nobrega, Antonio C. ^[24] ; Ribeiro, Antonio L. P. ^[25] ; Rodrigues-Sobrinho, Carlos R. ^[26] ; Sanjuliani, Antonio F. ^[27] ; Teixeira, Maria do Carmo B. ^[28] ; Krieger, Jose E. ^[3] ; Investigators, ReHOT

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^[1] Univ Sao Paulo, Med Sch, Heart Inst InCor, Hypertens Unit, Sao Paulo - Brazil

^[2] Univ Sao Paulo, Med Sch, Renal Div, Hypertens Unit, Sao Paulo - Brazil

^[3] Univ Sao Paulo, Med Sch, Lab Genet & Mol Med, Heart Inst InCor, Sao Paulo - Brazil

^[4] Univ Fed Sergipe, Div Cardiol, Aracaju - Brazil

^[5] Hosp Univ Clementino Fraga Filho, Dept Clin Res, Rio De Janeiro - Brazil

^[6] Univ Fed Espirito Santo, Dept Physiol Sci, Vitoria - Brazil

^[7] Univ Sao Paulo, Univ Hosp, Ctr Clin & Epidemiol Res, Div Internal Med, Sao Paulo - Brazil

^[8] Dante Pazzanese Inst Cardiol, Dept Hypertens & Nephrol, Sao Paulo - Brazil

^[9] Univ Fed Sao Paulo, Dept Med, Div Nephrol, Sao Paulo - Brazil

^[10] Pontificia Univ Catolica Rio Grande do Sul, Porto Alegre, RS - Brazil

^[11] Univ Fed Sao Paulo, Dept Cardiol, Sao Paulo - Brazil

^[12] Univ Cardiol Fdn, Inst Cardiol, Porto Alegre, RS - Brazil

^[13] Univ Fed Pernambuco, Dept Clin Med, Recife, PE - Brazil

^[14] Univ Fed Para, Dept Cardiol, Belem, Para - Brazil

^[15] Escola Bahiana Med & Saude Publ, Salvador, BA - Brazil

^[16] Sao Paulo State Univ, Botucatu Med Sch, Dept Internal Med, Div Nephrol, Botucatu, SP - Brazil

^[17] Univ Fed Rio Grande do Sul, Div Cardiol, Hosp Clin Porto Alegre, Porto Alegre, RS - Brazil

^[18] Univ Fed Bahia, Salvador, BA - Brazil

^[19] Univ Fed Goias, Fac Med, Goiania, Go - Brazil

^[20] Univ Fed Sao Paulo, Sch Med, Dept Cardiol, Sao Paulo - Brazil

^[21] Univ Estado Rio de Janeiro, Serv Cardiol, Hosp Univ Pedro Ernesto, Rio De Janeiro - Brazil

^[22] Univ Fed Ouro Preto, Dept Med, Ouro Preto, MG - Brazil

^[23] Univ Sao Paulo, Ribeirao Preto Med Sch, Sao Paulo - Brazil

^[24] Univ Fed Fluminense, Hosp Univ Antonio Pedro, Rio De Janeiro - Brazil

^[25] Univ Fed Minas Gerais, Dept Internal Med, Belo Horizonte, MG - Brazil

^[26] Univ Fed Ceara, Dept Cardiol, Fortaleza, Ceara - Brazil

^[27] Univ Estado Rio De Janeiro, Discipline Clin & Expt Pathophysiol, Rio De Janeiro - Brazil

^[28] Univ Estadual Ciencias Saude Alagoas, Maceio - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Hypertension; v. 71, n. 4, p. 681-690, APR 2018.
• Citações Web of Science: 22

Resumo

The aim of this study is to compare spironolactone versus clonidine as the fourth drug in patients with resistant hypertension in a multicenter, randomized trial. Medical therapy adherence was checked by pill counting. Patients with resistant hypertension (no office and ambulatory blood pressure {[}BP] monitoring control, despite treatment with 3 drugs, including a diuretic, for 12 weeks) were randomized to an additional 12-week treatment with spironolactone (12.5-50 mg QD) or clonidine (0.1-0.3 mg BID). The primary end point was BP control during office (<140/90 mmHg) and 24-h ambulatory (<130/80 mmHg) BP monitoring. Secondary end points included BP control from each method and absolute BP reduction. From 1597 patients recruited, 11.7% (187 patients) fulfilled the resistant hypertension criteria. Compared with the spironolactone group (n=95), the clonidine group (n=92) presented similar rates of achieving the primary end point (20.5% versus 20.8%, respectively; relative risk, 1.01 {[}0.55-1.88]; P=1.00). Secondary end point analysis showed similar office BP (33.3% versus 29.3%) and ambulatory BP monitoring (44% versus 46.2%) control for spironolactone and clonidine, respectively. However, spironolactone promoted greater decrease in 24-h systolic and diastolic BP and diastolic daytime ambulatory BP than clonidine. Per-protocol analysis (limited to patients with 80% adherence to spironolactone/clonidine treatment) showed similar results regarding the primary end point. In conclusion, clonidine was not superior to spironolactone in true resistant hypertensive patients, but the overall BP control was low (approximate to 21%). Considering easier posology and greater decrease in secondary end points, spironolactone is preferable for the fourth-drug therapy. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01643434. (AU)

• Processo FAPESP: 09/53282-8 - Estudo multicêntrico de pacientes com hipertensão arterial para identificação de pacientes resistentes e padronização de esquemas terapêuticos
• Beneficiário: Eduardo Moacyr Krieger
• Modalidade de apoio: Auxílio à Pesquisa - Pesquisa em Políticas Públicas para o SUS
• Processo FAPESP: 13/17368-0 - Genômica cardiovascular: mechanismos & novas terapias - CVGen mech2ther
• Beneficiário: José Eduardo Krieger
• Modalidade de apoio: Auxílio à Pesquisa - Temático